Welcome to Scribd, the world's digital library. Read, publish, and share books and documents. See more
Download
Standard view
Full view
of .
Save to My Library
Look up keyword
Like this
7Activity
0 of .
Results for:
No results containing your search query
P. 1
Submission of Summary Bio Equivalence Data for ANDAs Guidance

Submission of Summary Bio Equivalence Data for ANDAs Guidance

Ratings: (0)|Views: 9,362|Likes:
Published by FDA Lawyers Blog
Submission of Summary Bioequivalence Data for ANDAs FDA Guidance
Submission of Summary Bioequivalence Data for ANDAs FDA Guidance

More info:

Categories:Business/Law
Published by: FDA Lawyers Blog on May 10, 2011
Copyright:Attribution Non-commercial

Availability:

Read on Scribd mobile: iPhone, iPad and Android.
download as PDF, TXT or read online from Scribd
See more
See less

11/06/2012

pdf

text

original

 
 
Guidance for Industry
 
Submission of SummaryBioequivalence Data for ANDAs
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)May 2011Generics
 
 
 
Guidance for Industry
Submission of SummaryBioequivalence Data for ANDAs
 Additional copies are available from:Office of Communications Division of Drug Information, WO51, Room 2201Center for Drug Evaluation and ResearchFood and Drug Administration10903 New Hampshire Ave.Silver Spring, MD 20993-0002Phone: 301-796-3400; Fax: 301-847-8714druginfo@fda.hhs.govhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm 
U.S. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)May 2011Generics
 
Contains Nonbinding Recommendations
 
i
TABLE OF CONTENTS
 
I.
1. Immediate-Release Formulations Considered to Be the Same
……………………………..….4
 2. Immediate-Release Formulations Considered Not to Be the Same
……………………………5
3. Immediate-Release Formulations - Other 
………………………………………………..……
6
 
1. Extended-Release Formulations Considered to Be the Same
(Nonrelease Controlling Excipients)
6
 2. Extended -Release Formulations Considered Not to Be the Same
 (Nonrelease Controlling Excipients)
……………………………………………………………………...…..……….
7
3. Extended-Release Formulations - Other 
(Nonrelease Controlling Excipients)
………...………..……
7
 
1. Extended-Release
 
Formulations Considered to Be the Same
(Release Controlling Excipients)
……..
8
 
2. Extended-Release Formulations Considered Not to Be the Same
(Release Controlling Excipients)
 ...
8
3. Extended-Release Formulations - Other 
(Release Controlling Excipients)
 ...

Activity (7)

You've already reviewed this. Edit your review.
1 hundred reads
1 thousand reads
Peter Gargiulo liked this
kbuhring liked this

You're Reading a Free Preview

Download
/*********** DO NOT ALTER ANYTHING BELOW THIS LINE ! ************/ var s_code=s.t();if(s_code)document.write(s_code)//-->